Ultraview SL recall: Software Issue
Ultraview SL (UVSL) Command Module, Model 91496
Why was Ultraview SL recalled?
Command modules will display the following when parameter processing is suspended, depending on software version: 1) Older versions will have waveforms present with no alarms, 2) Newer versions have waveforms absent with no alarms. This may cause clinicians to miss a potentially catastrophic event.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Software version 2.03.06 and earlier and software version 2.04 and later.
- Product
- Ultraview SL (UVSL) Command Module, Model 91496
- Recalling firm
- Spacelabs Healthcare, Inc.
- Quantity
- 1,088
- Distribution
- US Nationwide distribution in the states of SD, KY, MO, WA, OH, NC, CA, OR, TX, GA, IL, OK, SC, PA, AL, KS, FL, ID, MI, MN, IA, NJ, MD, VA, AR, CT, NE, LA, AK, MS, ME, WV, NY, AZ, TN, WY, IN, MA, MT, CO, DE, ND, WI, NV, RI, NH, UT.
- Recall date
- May 10, 2023
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)